Senior Director, Quality Operations

Boldly innovating to create trusted solutions that detect, predict, and prevent disease.

Discover your power to innovate while making a difference in patients' lives. iRhythm is advancing cardiac care…Join Us Now! 

At iRhythm, we are dedicated, self-motivated, and driven to do the right thing for our patients, clinicians, and coworkers. Our leadership is focused and committed to iRhythm’s employees and the mission of the company. We are better together, embrace change and help one another.  We are Thinking Bigger and Moving Faster.

About this Role:

iRhythm is currently seeking an experienced Senior Director, Quality Operations.  The Senior Director, Quality Operations will provide strategic direction and tactical operation to the quality teams supporting commercial operations, clinical operations, and supply chain including supplier management, manufacturing, distribution and logistics, reverse logistics and product intake across US and OUS sites. The role is responsible for all aspects of quality, compliance and execution of the quality management system supporting clinical operations and supply chain. Our work environment is fast-paced, with a collaborative atmosphere. Most of all, we are passionate about delivering innovations that improve the quality of health care and the patient experience. We are looking for like-minded individuals to join our team today!

Specific job responsibilities include:

• Lead a diverse global team of Quality Directors, Managers, and Engineers supporting commercial operations, clinical operations, and supply chain across the US and OUS sites.
• Represent quality with our iRhythm independent testing diagnostic facility (IDTF) operations
• Responsible for the execution of site inspection readiness programs, for sites under areas of responsibility.
• Define & Monitor Quality Operations, metrics to drive product and system quality improvements
• Develops policies and requirements for Quality operations that optimize compliance and decrease risk while maintaining an effective and efficient supply chain.
• Responsible for the success of achieving functional strategies and objectives
• Approves and directs the implementation of Quality System improvements, standards and policies in alignment with iRhythm’s global quality management system.      
• Collaborate closely with head of Quality System, Design Quality, and Operations to ensure a robust and fully compliant Quality Management System.
• Establish and improve systems to monitor and improve product quality and lead quality improvement initiatives.   
• Participate, and or lead/host external audits such as FDA inspections and Notified Body audits,
• Represent area of responsibility in meetings with executive management.
• Evaluates organizations capabilities against industry standards and regulatory expectations; applies technical, business and compliance knowledge to improve results.
• Responsible for hiring, coaching and counseling employees in a rapidly growing organization. Maintain a highly effective and engaged organization, with personnel who are appropriately skilled and motivated to contribute to the success of the company
• Contribute to efforts to maintain a positive quality culture, with a quality team that is fully acting as business partners, while advocating for patients and customers’ needs.
• Assume additional responsibilities and performs other duties as assigned.

About You: 

• Willing to work on site
• Bachelor's degree required in Science, Engineering, Computer Science, or related medical/science/healthcare field; or equivalent experience. 
• Minimum of 15 years of professional experience in quality and regulatory roles in the medical device field
• At least 10 years of experience in a management position with direct reports. 
• Strong knowledge of medical device, GMPs, design control and risk management processes and regulations, including software as a medical device.
• Previous experience working in highly regulated environments working with regulatory directly with agencies such as FDA and EU Notified Bodies
• Demonstrated expert knowledge of regulations and standards such as ISO 13485, ISO14971, FDA 21 CFR 820, 806, 803, and EUMDR
• Previous experience leading organizations through regulatory compliance enforcement actions and challenges such as FDA warning letters.
• Direct experience leading and writing organizational responses to regulatory enforcement actions and audit findings.
• Direct experience with leading and hosting external regulatory and or third-party audits.
• Previous experience working and leading teams within a global environment
• High-level analytical skills an